Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

May 31, 2011 updated by: Novartis

An Open Label, Single Arm Study to Assess the Safety and Immunogenicity of Omalizumab Liquid Administered Subcutaneously to Male and Female Adolescents and Adults With Persistent Allergic Asthma

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Buenos Aires,, Argentina
        • Novartis Investigative Site,
      • Corrientes,, Argentina
        • Novartis Investigative Site,
      • Mendoza, Argentina
        • Novartis Investigative Site,
  • Germany
      • Nuremberg, Germany
        • Novartis Investigator Site
  • United States
    • Arizona
      • Scottsdale,, Arizona, United States, AZ 85251
        • Allergy & Immunology Associates, Ltd
    • California
      • Palmdale, California, United States, CA 93551
        • California Allergy and Asthma Medical Group
      • San Diego, California, United States, CA 92120
        • Allergy Associates Medical Group, Inc,
      • Stockton, California, United States, CA 95207
        • Bensch Research Associates
    • Colorado
      • Centennial, Colorado, United States, CO 80112
        • 1st Allergy and Clinical Research Center
    • Florida
      • Largo, Florida, United States, FL 33770
        • Innovative Research of West Florida, Inc.
    • Georgia
      • Albany, Georgia, United States, GA 31707
        • Georgia Pollen
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Allergy & Asthma
    • Minnesota
      • Minneapolis, Minnesota, United States, MN 55402
        • Asthma and Allergy Specialists, PA
    • Missouri
      • St. Louis, Missouri, United States, MO 63141
        • : The Clinical Research Center, LLC
    • New Jersey
      • Brick, New Jersey, United States, NJ 08724
        • Allergy, Asthma and Clinical Immunology
      • Mt. Laurel, New Jersey, United States, NJ 08054
        • Asthma & Allergy Research of NJ, Inc.
    • New York
      • Massapequa, New York, United States, NY 11758
        • Nassau Chest Pysicians, PC
    • North Carolina
      • High Point, North Carolina, United States, NC 27262
        • Allergy and Asthma Center of NC, PA
    • Ohio
      • Columbus, Ohio, United States, OH 31904
        • Allergy Center at Brookstone
      • Sylvania, Ohio, United States, OH 43650
        • Toledo Center for Clinical Research
      • Toledo, Ohio, United States, OH 43617
        • Asthma and Allergy Center
    • Oregon
      • Corvallis, Oregon, United States, OR 97330
        • The Corvallis Clinic, PC
      • Lake Oswego, Oregon, United States, OR97037
        • Allergy, Asthma & Dermatology Research Center
      • Medford, Oregon, United States, OR 97504
        • Clinical Research Institute of Southern Oregon, PC
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, PA 19422
        • Allergy & Asthma Specialists, PC
      • Philadelphia, Pennsylvania, United States, PA 19107
        • Asthma Allergy & Pulmonary Associates, PC
    • Rhode Island
      • Providence,, Rhode Island, United States, RI 02906
        • AAPRI Clinical Research Institute
    • Texas
      • Fort Worth, Texas, United States, TX 76132
        • North Texas Institute for Clinical Trials
      • Houston, Texas, United States, TX 77070
        • Clinical Trials of North Houston
      • Houston,, Texas, United States, TX 77054
        • Allergy and Asthma Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 12 years old or above with moderate to severe allergic asthma
  • Body weight greater than 30kg and less than 150 kg and total serum IgE level greater than 30 to less than 700 IU/ml
  • Diagnosis of allergic asthma greater than 1 year duration, according to the American Thoracic Society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
  • Positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
  • No clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (Visit 1) and during screening period (between Visit 1 and 2)
  • Demonstrated evidence of inadequate asthma symptom control, despite treatment with ICS according to clinical features of moderate to severe persistent asthma.

Exclusion Criteria:

  • Previous exposure to omalizumab
  • Previous exposure to other humanized proteins or monoclonal antibodies
  • Known HAHA to other monoclonal antibodies
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
  • Known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
  • Active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
  • Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period
Time Frame: 16 weeks after last dose
An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.
16 weeks after last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period
Time Frame: 24 weeks treatment period + 4 weeks for following up participants
The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.
24 weeks treatment period + 4 weeks for following up participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period
Time Frame: Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)
The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).
Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Genentech, Inc.
Tanox

Investigators

  • Principal Investigator: Jose Bardelas, MD, Allergy and Asthma center of North Carolina, PA, High Point, NC 27262

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Estimate)

June 2, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIGE025C2303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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